Radioisotopes Manufacturing Program Manager

Responsibilities

• Operational Leadership
• Own end to end manufacturing performance, including production planning, throughput, yield, and resource allocation.
• Lead day to day operations within hot cell and glovebox environments while ensuring compliance with all GMP, radiological, and safety requirements.
• Oversee execution, review, and continuous improvement of production processes, batch documentation, and data integrity practices.
• Drive troubleshooting and technical issue resolution in coordination with radiochemists, engineers, radiation safety, quality, and industrial safety.
• Ensure operations comply with FDA expectations for API starting material production, NRC and DOT radioactive material requirements, and applicable state and OSHA regulations.
• Partner closely with Quality on deviations, CAPAs, nonconformances, change controls, and internal/external audits.
• Maintain validated processes and equipment, ensuring changes follow approved validation and change control pathways.
• Cross Functional Coordination
• Coordinate with the Everett Laboratory (EVL) Manager to align manufacturing needs with other project and facility activities.
• Work with Maintenance Engineering and Facility Maintenance to plan outages, maintain equipment readiness, and support maintenance activities.
• Collaborate with Logistics to maintain adequate inventories of consumables, chemicals, and production-support materials.
• Partner with Radiation Safety and Health Physics to manage radiological work planning, radioactive materials inventory, contamination control, and waste handling.

Qualifications and Skills

• Bachelor’s degree in chemical engineering, radiochemistry, pharmaceutical sciences, or related laboratory or engineering discipline.
• Minimum 8 years of experience working with radioactive materials under an established radiation protection program; alpha-emitter experience preferred.
• Leadership or supervisory experience in a regulated manufacturing environment (radiopharmaceutical, nuclear pharmacy, GMP chemical manufacturing, or comparable field) preferred.
• Strong working knowledge of FDA regulations for pharmaceutical/API starting materials, NRC and DOT regulations for radioactive materials, and applicable state health and OSHA requirements.
• Demonstrated ability to lead technical teams, manage priorities, and coordinate cross-functional work in a high-hazard environment.
• Effective written and verbal communication skills in English.
• Military experience is a plus.

Job Functions

• Sitting for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)
• Prolonged repetitive work
• Visual and audio focused work
• Stairs, typing/keyboard, standard and/or sitting working environment of >8 hours/day
• Travel required 0-10%

Benefits

• Competitive Compensation
• Salary, eligible to participate in discretionary short-term incentive payments
• Comprehensive Medical and Wellness Benefits
• Medical
• Vision
• Dental
• Life and Disability
• Gender Affirmation Benefits
• Parental Leave
• 401k Plan
• Generous Paid Time Off (PTO)
• 21 days of annually accrued PTO
• Generous Holiday Schedule
• 10 paid holidays
• Relocation Assistance
• Professional and Educational Support Opportunities

Job Details

• Salary Range: $168,316 - $252,475
• We typically place offers in the lower to middle portion of the range to maintain internal equity and allow room for growth. Any salary offered within the posted salary band is based on market data and commensurate with the selected individual’s qualifications experience.